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Siemens Medical Solutions USA, Inc recalls Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiograph
Recalled October 8, 2014 · FDA recall Z-0005-2015 · Siemens Medical Solutions USA
Hazard
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images · FDA Class II
Units
5
Sold at
Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
Description
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images
Product
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →